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Prediabetes (PD) was defined as an state in which glucose levels are above normal but not enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with IGT, it is expected that by 2035 this number will increase to 417 million people affected. Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including: increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose utilization in various ways and inhibition of glucose uptake in the intestine.
The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic control, insulin secretion and insulin sensibility on patients with IGT. The investigators will conduct a double-blind trial, randomized, placebo control group, each group 12 female and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9 kg / m2. Randomization will determine who will receive the intervention during the 9-week trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and dinner or homologated placebo capsules). The clinical findings and laboratory tests include a metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight, body fat, BMI and blood pressure will be determined during the initial and final visit. Adverse events and adherence to treatment will be documented. Statistical analysis: Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p <0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gymnema Sylvestre | Experimental | Patients with IGT |
|
| Placebo | Placebo Comparator | Patients with IGT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gymnema Sylvestre | Drug | Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose | After intervention by spectrophotometry | 90 days |
| 2-hour Post Load Plasma Glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | 90 days |
| Glycated Hemoglobin A1c (A1C) | After intervention by high-performance liquid chromatography | 90 days |
| Total Insulin Secretion (Insulinogenic Index) | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention. | 90 days |
| First Phase of Insulin Secretion | First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0') after intervention. | 90 days |
| Insulin Sensitivity (Matsuda Index) | Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] after intervention. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Glucose | Area under the curve of glucose was obtained using the trapezoidal integration. | 90 days |
| Area Under the Curve of Insulin | After intervention area under the curve of insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esperanza Martínez-Abundis, PhD | Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gymnema Sylvestre | Patients with impaired glucose tolerance (IGT) Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
| FG001 | Placebo | Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gymnema Sylvestre | Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
| BG001 | Placebo | Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fasting Plasma Glucose | After intervention by spectrophotometry | All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat). | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
Adverse events were collected throughout the 90 days of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gymnema Sylvestre | Patients with IGT Gymnema Sylvestre: Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrea | Gastrointestinal disorders | ANY | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dra. Esperanza Martínez Abundis | Institute of Experimental and Clinical Therapeutics | +52-33-10-58-52-00 | 34211 | esperanzamartnezabundi@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 18, 2016 | Nov 12, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C075206 | Gurmarin protein, Gymnema sylvestre |
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| Placebo | Drug | Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner |
|
|
| 90 days |
| Body Weight (BW) | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | 12 weeks |
| Body Mass Index (BMI) | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | 12 weeks |
| Waist Circumference (WC) | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12 | 12 weeks |
| Systolic Blood Pressure (SBP) | The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | 12 weeks |
| Diastolic Blood Pressure (DBP) | The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | 12 weeks |
| Total Cholesterol | After intervention by spectrophotometry | 90 days |
| Triglycerides | After intervention by spectrophotometry | 90 days |
| High Density Lipoprotein Cholesterol | After intervention by spectrophotometry | 90 days |
| Low Density Lipoprotein | After intervention by spectrophotometry | 90 days |
| Very Low Density Lipoprotein | After intervention by spectrophotometry | 90 days |
| Creatinine | After intervention by spectrophotometry | 90 days |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Weight (BW) | The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal. | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres. | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference (WC) | The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters. | Mean | Standard Deviation | cm |
|
| Systolic blood pressure (SBP) | The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg. | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure (DBP) | The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg. | Mean | Standard Deviation | mmHg |
|
| Triglycerides (TGs) | The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Total cholesterol (TC) | The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| high-density lipoprotein cholesterol (HDL-C) | Mean | Standard Deviation | mmol/L |
|
| Low-density lipoprotein cholesterol (LDL-C) | The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Very-low density lipoprotein (VLDL) | The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5 . The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Fasting plasma glucose (FPG) | The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| 2-hour postload plasma glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Mean | Standard Deviation | mmol/L |
|
| Glycated hemoglobin A1c | Mean | Standard Deviation | Percent of glycated hemoglobin |
|
| Creatinine | Mean | Standard Deviation | µmol/L |
|
| Area under the curve of glucose (AUCG) | The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min. | Mean | Standard Deviation | mmol/L/min |
|
| Area under the curve of insulin (AUCI) | The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min. | Mean | Standard Deviation | pmol/L/min |
|
| Total insulin secretion | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose). | Mean | Standard Deviation | unitless |
|
| First phase of insulin secretion | First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'). | Mean | Standard Deviation | unitless |
|
| Insulin sensitivity | Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. | Mean | Standard Deviation | unitless |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 2-hour Post Load Plasma Glucose (2-h PG) | The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L. | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Primary | Glycated Hemoglobin A1c (A1C) | After intervention by high-performance liquid chromatography | Posted | Mean | Standard Deviation | Percent of glycated hemoglobin | 90 days |
|
|
|
| Primary | Total Insulin Secretion (Insulinogenic Index) | Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose) after intervention. | Posted | Mean | Standard Deviation | Unitless | 90 days |
|
|
|
| Primary | First Phase of Insulin Secretion | First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0') after intervention. | Posted | Mean | Standard Deviation | Unitless | 90 days |
|
|
|
| Primary | Insulin Sensitivity (Matsuda Index) | Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)] after intervention. | Posted | Mean | Standard Deviation | Unitless | 90 days |
|
|
|
| Secondary | Area Under the Curve of Glucose | Area under the curve of glucose was obtained using the trapezoidal integration. | Posted | Mean | Standard Deviation | mmol/l/min | 90 days |
|
|
|
| Secondary | Area Under the Curve of Insulin | After intervention area under the curve of insulin | Posted | Mean | Standard Deviation | mmol/l/min | 90 days |
|
|
|
| Secondary | Body Weight (BW) | The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
|
| Secondary | Body Mass Index (BMI) | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks |
|
|
|
| Secondary | Waist Circumference (WC) | Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12 | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
|
|
| Secondary | Systolic Blood Pressure (SBP) | The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) | The Diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12 | Posted | Mean | Standard Deviation | mmHg | 12 weeks |
|
|
|
| Secondary | Total Cholesterol | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Triglycerides | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | High Density Lipoprotein Cholesterol | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Low Density Lipoprotein | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Very Low Density Lipoprotein | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | mmol/L | 90 days |
|
|
|
| Secondary | Creatinine | After intervention by spectrophotometry | Posted | Mean | Standard Deviation | µmol/L | 90 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | Placebo | Patients with IGT Placebo: Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner | 0 | 15 | 0 | 15 | 6 | 15 |
| Abdominal distention | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Anorexy | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Sweet taste intolerance | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | ANY | Non-systematic Assessment |
|
| Polydipsia | General disorders | ANY | Non-systematic Assessment |
|
| Headache | Nervous system disorders | ANY | Non-systematic Assessment |
|
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